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Completed

NCT Number: NCT00092001

Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer

The purpose of this study is to test whether SU011248 has activity and is safe in patients with metastatic non-small cell lung cancer (NSCLC) who have failed a platinum-containing regimen and docetaxel.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Orbassano (Torino), Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed advanced or metastatic Non-Small Cell Lung Cancer that cannot be cured with surgery, radiation, or combination thereof
  • No more than 2 prior chemotherapy treatments including treatment with a platinum containing therapy
  • Evidence of measurable disease by radiographic technique
  • Male or Female, 18 years or older
  • ECOG performance status of 0 or 1
  • Resolution of all acute toxicities of prior therapies
  • Adequate organ function

Exclusion criteria

  • Major surgery or radiation therapy within 4 weeks
  • Severe hemorrhage within 4 weeks
  • Previous treatment with anti-angiogenesis agents
  • Diagnosis of second malignancy within last five 5 years
  • History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
  • Known HIV
  • Serious acute or chronic illness
  • Current treatment on another clinical trial
  • Pregnant or breastfeeding

Treatment and study plan

Sunitinib

Drug

Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.

Other names: Sutent, SU011248

Primary outcomes

  1. Overall confirmed objective response rate (ORR)

    Time frame: From screening until at least 28 days beyond discontinuation of study treatment.

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: From screening until disease progression or discontinuation of study

  2. Time to progression (TTP)

    Time frame: From screening until disease progression or discontinuation of study

  3. Duration of response (DR)

    Time frame: From screening until disease progression or discontinuation of study

  4. Overall survival (OS)

    Time frame: From screening until disease progression or discontinuation of study

  5. Probability of survival at 1 year

    Time frame: From screening until disease progression or discontinuation of study

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 27, 2004
Registry last updated
Oct 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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